Expo 5F Selective Angiographic Catheters — Class I medical device recall Z-1683-2024

Ongoing recall by Boston Scientific Corporation, reported 2024-05-22. An increase in complaints related to an inability to advance the guidewire through the lumen of the device for

Recall number	`Z-1683-2024`
Product type	Medical device
Classification	Class I
Status	Ongoing
Voluntary or mandated	Voluntary
Recalling firm	Boston Scientific Corporation, Maple Grove, MN, United States
Recall initiated	2024-03-21
Classified	2024-05-10
Reported by FDA	2024-05-22
Countries outside the US	CA
Quantity	37,252 catheters
Reason classes	device malfunction
UPC / GTIN / UDI-DI	`08714729187936`
Lot numbers	`60438199`, `60438660`, `60440956`, `60445923`, `60448986`, `60449233`, `60453733`, `60459203`, `60465786`, `60465788`, `60467041`, `60467087`, `60472577`, `60473158`, `60477280`, `60477281`, `60477282`, `60486299`, `60486300`, `60491662`, `60495526`, `60495527`, `60498225`, `60498226`, `60500754`, `60507655`, `60507656`, `60511179`, `60511181`, `60512377`, `60513563`, `60529457`, `60533641`, `60538216`, `60538217`
Model numbers	`AL1`, `H74908526962`

Product

Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO AL1 (5PK), REF H74908526962; cardiac catheter

Reason for recall

An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the catheters inner lining.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1683-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.